Would You Take Lemtrada for Multiple Sclerosis?

The Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for treatment of relapsing-remitting multiple sclerosis. Based on the information released about the drug thus far, would you take this medication?

Advertisement

Lemtrada had a rocky road on the way to approval for multiple sclerosis. However, it staggered across the finish line complete with a boxed warning listing all of its serious and even fatal possible effects.

To make the approval even more questionable, the drug will be available only through a limited distribution program, and certified pharmacies, prescribers, and patients will be the only ones allowed access. Alemtuzumab also is considered to be a third-line treatment option for the disease, according to Genzyme (a Sanofi company), the manufacturer.

Boxed warning and side effects
The boxed warning required to appear on the medication states the following:

That its use may cause “serious, sometimes fatal autoimmune conditions such as immune thrombocytopenia (2% of patients in trials) and anti-glomerular basement membrane disease.”

That it is associated with an increased risk of lymphoproliferative disorders, thyroid cancer, and melanoma

That patients should be monitored for 48 months after their last infusion using complete blood counts with differential, serum creatinine levels, and urinalysis

In addition:

Use of Lemtrada was associated with new cases of autoimmune thyroid disorders in 34 percent of patients.

About Lemtrada and multiple sclerosis
Alemtuzumab is not a stranger to the healthcare market. For years, individuals with certain types of leukemia have been treated with this drug under the name Campath.

Advertisement

Now, recent clinical trials have shown that alemtuzumab may be helpful in MS. The drug targets a protein called CD52, which is abundant on B and T cells. These cells are believed to be involved in the inflammatory process in the disease.

Alemtuzumab temporarily depletes the number of circulating T and B cells after treatment. Over time, the cells repopulate but immune response changes so that the body’s attack of myelin is reduced or shut down in most individuals.

In clinical trials for drug approval, Lemtrada was significantly more effective than interferon beta-1a when it came to reducing relapse rate: a 55 percent relative reduction. After two years, the percentage of patients who remained relapse-free was 78 percent for individuals who took Lemtrada and 59 percent for those taking interferon beta-1a.

In a second trial, the percentage of patients who remained free of relapse was 65 percent for Lemtrada users and 47 for those taking interferon beta-1a. The amount of change in lesion volume between the two groups was not significantly different.

Using Lemtrada

Lemtrada is administered via infusion. The first dose is given at 12 mg daily for five consecutive days. The second dose is administered 12 months later for three consecutive days. Before each treatment period and for the first three days, patients must take high doses of corticosteroids (1,000 mg methylprednisolone or equivalent). Another requirement is use of an anti-viral prophylaxis for herpes taken on the first day of treatment and continuing for two months.

Lemtrada is the latest in a series of medications developed for treatment of relapsing-remitting multiple sclerosis. Concerns over the safety of this drug resulted in strong label warnings, including the caveat that it should “generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.”

Comments

This drug is one example of many drugs the FDA has approved in recent years with many serious and fatal side effects. The benefit of such a drug should be total cure of disease if a patient is to risk serious new disease or death just by trying it.
The FDA has in the last decade made approvals of GMO plants and fish, cancer drugs that were slightly better than the ones already in long term use but the newer ones with more side effects, and generally allowing the citizenry to be poisoned and killed by these highly toxic drugs.
It is a well known fact among doctors that cancer patients nowadays have a greater chance of dying from drug toxicity than from the spread of the cancer itself. The drugs kill so many cells and damage so many organs the patient cannot recover even if the cancer is all gone.
Traditional medicine wonders why so many patients are turning to natural cures and natural supplements and asking the FDA to stop this mad trail of approvals.
The bottom line, and it is always the bottom line, is that these drug companies stand to make billions with a B every year with these new drugs. Even common drugs now cost from 5 to 7 dollars each and cost is rising. Generic makers now have gotten on the wagon and generics are skyrocketing as the number of competitors who make them are dwindling.
Patient Beware! Patient Educate Yourself! You can no longer trust your cancer doctor, the drug companies, or the FDA to protect your health by regulating what poisonous medications they approve for you to use.

I understand what you're saying, but i've had my 1st spinal hit, and i believe Lemtrada is the way to go for me. I have 2 little girls who i would very much like to be here for, and not as a sideline mum. Last month when i couldn't change a nappy without causing my baby to sob hysterically was heartbreaking. A full cure, WOULD be nice, but to SOME people this is a cure, that's a chance i'm willing to take x

I would rather take my chance on a drug then be a 43 yr old man stuck in a wheelchair for the rest of his life. That's not where I am now but where I'm headed. Yes this drug comes with big side effects but so does MS. I have a family that I would like to be able to do a few thinks with and have some mobility. We all have our own opinions and we all have to make our own choices. Anyone taking this drug I wish u good luck. I started my first dose today.

Joe Morgan your comments have no meaning to this drug. You have an issue.
I've taken this drug. Currently on it. There are serious side effects to rhis drug and these were discussed with me and my dr. I don't know if I had the chance if I would do this again.

Joe: Thank you for sharing your thoughts. I wholeheartedly agree that as healthcare consumers, we need to take charge and be vigilant, exploring all the info available on any medication put on the market. The same goes for natural and alternative/complementary approaches. Patients are typically guinea pigs for products that are making a few individuals and corporations very wealthy.

One thing for consumers to consider, and I approach my own health care this way, is to try to stick with medications and treatments that have been around for longer. "New" treatments are more frightening and can certainly be reserved when others fail. But if you have an option of a therapy that has been around and the effects are known you might consider going that route. Also, many chemotherapy drugs do well, but it is the milder ones and it depends on the cancer type and so much more. I would never encourage anyone to completely shun traditional cancer care. I love the way some centers are blending complementary and alternative medicine with Western. Finally!

Well, that's one way to look at it. But not the only way. Lemtrada has potentially fatal side effects. However, all of those side effects can be managed if caught early enough. That's why those who receive the drug must get checked monthly for 4-5 years after the final treatment for signs of those side effects. That's the specialized program you're talking about. Lemtrada is not the only MS drug with such a program (see Tysabri).
All MS drugs come through specialty pharmacies, and even without special programs, most require regular blood draws and MRIs. This is the world MSers live in. We'd rather not, but that's how you fight MS.
Now, let's look at the upside. Some people get the two rounds of treatment and never need any more treatment. Their MS seems to stop. Some even get a reversal of current symptoms. Who are these lucky people? Those who take the drug early--before they have a lot of damage. So while nobody dares to say Lemtrada cures MS, it kind of looks like it does for some people.
Now put yourself in the shoes of a person living with MS. Every attack leads to damage that you generally don't heal from completely. It saps your energy, increases the likelihood you'll have to leave your job. It might make you pee your pants, take your vision, rob you of your memory, rob you of your speech. And then of course there's the wheelchair. Worst of all, it causes your brain to shrink at double or triple the rate of the average person. The current MS drugs slow the damage down, sure. But most of us are all still on a long slow march to the progressive phase of the disease. If you feel bad today, it's very likely you'll feel even worse tomorrow, next year, 5 years from now.
Maybe Kathleen wants to wait around to see how things work out for a couple years, but I don't.
MSers have been taking Lemtrada (Campath) in research labs and clinical trials for decades with good results. Some died, that's true. Then researchers made adjustments to make it safer. Personally, I'm hoping to use the drug as soon as it gets through to those pharmacies/programs/prescribers (My neurologist has already agreed to give it to me.)

Good for you Bennie. I hope you are approved ASAP. I'm researching this drug right now, my neurologist believes it 'might' help me. I'm not 100% sure of it. Good luck and give us updates when you can please.

Good for Bennie I have been battling this nasty disease since 1998, was treated with Avonex and Copaxone without benefit, the disease continued to progress, I am a healthcare practitioner and when I read the clinical trial data on Tysabri, I wanted the biologic, However it was very difficult to find a neurologist to rx Tysabri in 2005. Was a week away from receiving my first dose in 04 when FDA yanked it. I called Jim Mullen CEO of biogen at the time and within one week I received my first dose of Tysabri, MRI's since showed no new lesions, no progression of disease. I have been seeking Lemtrada since 2011, as I am JC positive and have received over 115 Tysabri infusions. I have reviewed the clinical trials by Dr Alastair compston @ Cambridge, now we have an agent that is showing reversal of lesion load, I almost flew to Germany for Lemtrada in 2013 prior to FDA approval however $110 K, and my Neuro promised me that I would be one of the first patients at Stanford Medical Center to be infused with Lemtrada once FDA approved. I am still waiting, months later, still hoping they will infuse Lemtrada, in the meantime I called Genzyme and informed them that I am seeking Lemtrada and asked for their assistance and I am contacting other neurologists who r rx Lemtrada in the event Stanford continues to withhold Lemtrada. This is a very frustrating and stressful situation, for a medical facility to promise their patient a medicine, then not follow through. I believe the best approach to Multiple Sclerosis is treatment with the most effective agents, to control progression. We are fortunate that we have access to these biologics to battle MS, as patients did not have choices, and their disease process took hold, and they lost quality of life. Folks that are cynical and negative about the Pharma industry are most likely cynical and negative regarding other aspects of life. I can guarantee as a healthcare provider and as a patient that has been battling MS this long, that if one is paralyzed, unable to speak, swallow, see, as I have been during severe exacerbations, that they would do everything and anything including taking on risk with these biologics to battle their disease process. Happy your neuro has agreed to give Lemtrada to you! God Bless you and keep up the positive attitude. Leslie

Good for Bennie I have been battling this nasty disease since 1998, was treated with Avonex and Copaxone without benefit, the disease continued to progress, I am a healthcare practitioner and when I read the clinical trial data on Tysabri, I wanted the biologic, However it was very difficult to find a neurologist to rx Tysabri in 2005. Was a week away from receiving my first dose in 04 when FDA yanked it. I called Jim Mullen CEO of biogen at the time and within one week I received my first dose of Tysabri, MRI's since showed no new lesions, no progression of disease. I have been seeking Lemtrada since 2011, as I am JC positive and have received over 115 Tysabri infusions. I have reviewed the clinical trials by Dr Alastair compston @ Cambridge, now we have an agent that is showing reversal of lesion load, I almost flew to Germany for Lemtrada in 2013 prior to FDA approval however $110 K, and my Neuro promised me that I would be one of the first patients at Stanford Medical Center to be infused with Lemtrada once FDA approved. I am still waiting, months later, still hoping they will infuse Lemtrada, in the meantime I called Genzyme and informed them that I am seeking Lemtrada and asked for their assistance and I am contacting other neurologists who r rx Lemtrada in the event Stanford continues to withhold Lemtrada. This is a very frustrating and stressful situation, for a medical facility to promise their patient a medicine, then not follow through. I believe the best approach to Multiple Sclerosis is treatment with the most effective agents, to control progression. We are fortunate that we have access to these biologics to battle MS, as patients did not have choices, and their disease process took hold, and they lost quality of life. Folks that are cynical and negative about the Pharma industry are most likely cynical and negative regarding other aspects of life. I can guarantee as a healthcare provider and as a patient that has been battling MS this long, that if one is paralyzed, unable to speak, swallow, see, as I have been during severe exacerbations, that they would do everything and anything including taking on risk with these biologics to battle their disease process. Happy your neuro has agreed to give Lemtrada to you! God Bless you and keep up the positive attitude. Leslie

My nerologists in Croatia have been talking about Campath since 2008. It has finally been approved here in 2013 and my neuro now reccommends it for my case since Rebif hasn't been really effective. I haven't yet decieded between that and gilenya. The fact that is's like chemo scares me!

I did my round of lemtrada in June of this year and the only thing that really happened forbme was I got hives for the week of infusions. It took a couple months for my immune system to recover fully but after a month it was good enough I didn't catch any thing but I careful not to but my self where I would I stayed away from hospitals or and where with big crowds. At this point I have recovered fully and besides to blood tests once a month which is no more then a little hassle , I have no new lesions. The word chemo is a little scary but the the side effects from Gilenya scared me more.

Conflicted and scared but the ms drug's come at great physical costs potentially. I'm not inclined to wait for my disabilities to add up, my Dr and wife are seriously discussing Lemtrada. Trying to figure how much time out of work I need and how to set that up with employer. Thanks for sharing your thoughts it helps. Warren

I understand Bennie - completely. I wish you nothing but the best with this new treatment. It will be exciting, and if "cures" are being seen......I imagine I wouldn't wait for 5 years either. :) Thank you.

People that are complaining about the risks that come with MS drugs do not understand the seriousness of MS. It is a chronic progressive disease that attacks the brain, optic nerves and spinal cord (CNS) with at best only temporary remissions in obvious disabilities. The disease progresses even as the CNS tries to recover. It is a losing proposition going forward and unless you have lived with some of the nastiest results (and I do), you will never understand the suffering that is MS. All of the most effective MS drugs come with potentially serious or fatal side effects and at best only delay the onset of disabilities. I have taken 2 drugs that can lead to death from a vicious brain infection and another that can make your heart stop. MS patients fighting aggressive forms of the disease know all too well what the risks are and are willing to weigh the odds. There is more than enough information available for patients and their doctors rather than bureaucrats to decide what is in the patient's best interest. Researchers have called Lemtrada a game changer and the trial data which compared it to the widely used interferon Rebif suggested the differences were so great as to make Rebif appear as a placebo. I know patients firsthand that participated in the trials or went offshore for treatment with great results. Up to 80% of patients did not require further treatment beyond month 12. So what if you need to be monitored for 48 months? MS patients now take powerful immune suppressing drugs for life. We are quite familiar with being monitored. I personally have scheduled an appointment for next month to arrange for receiving the Lemtrada It cannot happen soon enough for me and I only wish that I could have participated in the clinical trials.

I am 20 with rrms i hope I will be eligible for this so i have another treatment option but I only will if my mri in feb shows more scarring of the brain. Im stuck between it all right now... im scared what will happen if I dont take anything and im scared what will happen if I do. I dont want another problem added on to my ms I.e thyroid problems.... nor do I want to have my ms to progress faster.
Im feel stuck. The only thing that puts me at ease mentally is the fact that you never know when you will die, either being hit by a car or being taken by a result of ms treatments... Basically im saying you never know the end result of life. Id rather like to think a car crash will take me and not slow painful illnesses that ms drugs could potentially bring.. but I dont want to lose my bodily function. Im so confused...

All reasonable fears. But, I am a software engineer and believe in letting logic guide me rather than fear. Lemtrada will only be available in the US after failing 2 other treatments. I suggest you get there as fast as possible because Lemtrada is the only DMD that shows 70% - 80% of clinical trial patients required no further treatment beyond 12 months. That means there was no further progression of the disease detected via MRI or clinically for 5 years and many of the patients saw reversal of disabilities. I know patients that support this. Thyroid disorders are easily detected and treated simply with 1 pill a day. I currently take over 30 pills a day to do a miserably job at controlling my MS symptoms which I have attacked as aggressively as possible since my DX in 2005. You are so lucky to have the chance to get Lemtrada as soon as possible to stop MS which has been devastating to me. All MS DMDs have serious potential side effects; but only Lemtrada comes with evidence of stopping and possibly reversing the symptoms of MS without requiring continuous treatment for the rest of your life.

I will be starting on lemtrada very soon... just waiting on insurance approval.. I am nervous.. I was on tysabri but was jcv positive so I could only be on that short term... I will continue to research this drug.... if anyone has been on it and can say how it has made them feel and how their MS responded to this that would be great... thanks good luck to everyone dealing with this disease....

Hi Michelle. My wife is currently on Tysabri but due to a recent high blood titre (JC virus +), the plan is to switch to Lemtrada in a couple of months. My greatest concern regards the amount of time you have to be off Tysabri before starting Lemtrada. She came off Tysabri for two months in 2012 as she was pregnant but relapsed very badly as a result. She has recovered and is living an active life with me and our beautiful daughter. I would love to hear from people out there who successfully switched from Tysabri to Lemtrada.

Thank you so much for your positive comments re: Lemtrada. I too will be starting this drug soon and have many concerns as well. I also know there are many warnings associated with ANY drug and companies MUST warn everyone re: possible side effects.
If I have any chances of possibly reversing disabilities..why not?
MS has affected me in terms of mobility and balance issues.
Cheers!

I am exactly where you are on this! I cannot make a decision.. I feel like I wont chose it unless my ms is really bothersome but then its like, have I waited to long,, and like you say what if it doesn't work and i'm adding other problems like thyroid disease meaning i have to take even more drugs,, which I don't like doing to my body. Its a tough one.

Thank you all for sharing your thoughts on Lemtrada. I am supposed to be starting it soon. I am nervous, for sure. I have been on several other drugs , which either didn't work, or I couldn't take because of the reactions.

Currently on Tysabri with JC, looking at other options Gilenya / Tecfidera / Lemtrada.
Tysabri treated me well making my MS not so obvious but now I need to change tactics due to my high JC level.
Which way do I go? I am swaying between Gilenya and Lemtrada. I don't know if I should hit hard with Lemtrada when Gilenya may do and I can then have Lemtrada in reserve, if need be. Does anyone have a crystal ball I can borrow. I have 3 children and don't want to be in a position where I am less able to assist them in growing up.
Love to hear you thoughts, advice, anything that me help me in my decision making.
My Neurologist has given me a week to think about it so a plan can be made to implement the drug of choice.
Arrrgghhhh!

I’m 29 , I was dx with MS in 2008. I started with Copaxone in 2008 - MRI found new lesions so switch to Tysabri 2009-2012 (JC-VIRUS positive I stop taking because I was scared) started Gilenya 2012-2013 new lesions was found) so I was switch to Current medication *Tecfidera* with this medications I’ve had 5 flare’s up which I never had no flare up with previous therapy since 2008 but my physician saw the new lesions and had to find a more aggressive therapy. Lemtrada has been recommended and I’m about to start another journey. Thanks for your reviews

I’m 29 , I was dx with MS in 2008. I started with Copaxone in 2008 - MRI found new lesions so switch to Tysabri 2009-2012 (JC-VIRUS positive I stop taking because I was scared) started Gilenya 2012-2013 new lesions was found) so I was switch to Current medication *Tecfidera* with this medications I’ve had 5 flare’s up which I never had no flare up with previous therapy since 2008 but my physician saw the new lesions and had to find a more aggressive therapy. Lemtrada has been recommended and I’m about to start another journey. Thanks for your reviews

Former NHL player Bryan Bickell is battling Multiple Sclerosis (MS) but feeling great with Tysabri. Bickell may be off the ice, but he is on to bigger things as spokesperson for Biogen and running his non-profit, the Bryan and Amanda Bickell Foundation which helps rescue abused pit bulls and provide people in need with service dogs. The 31-year-old Bickell announced his plans to retire from the NHL after a successful 2016-2017 season as winger with the Carolina Hurricanes.

Living with Multiple Sclerosis meanscoping with a number of daily challenges. These stories of people living with MS tell that fatigue, pain, brain fog, constipation, hands feeling swollen like balloons, feet on fire, tingling pins and needles are all daily problems to be dealt with.

Results of a new trial suggest that certain probiotics can improve mental health, metabolic function, and disability among individuals with multiple sclerosis. This study is just one of several that has explored the impact of beneficial bacteria on the symptoms and progression of multiple sclerosis.